Berlin Heart GmbH
DE-MF-000006521 · Germany · Berlin
Berlin Heart GmbH is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 13 |
|---|---|
| Class I | 70 |
| Class IIb | 9 |
Among these devices, 90 are declared sterile, 66 implantable, 2 active, 1 with a measuring function.
Catalogue references include A12-012m, C22V-004, C27A-001, C60G-002, C60G-002m, C80G-021m.
European nomenclature codes declared: C03010499, C03010101, Z12050201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BERLIN HEART GMBH (DE) · FDA 3004582654 |
| Devices in EUDAMED | 92 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 92 |
|---|---|
| Found in the U.S. device database | 64 |
| Share | 69.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BERLIN HEART GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 1 |
| First licensed | 2009-01-23 |
Licence types: System (1).
Licensed under: EXCOR SYSTEM.
North American profile: Both markets. Berlin Heart GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 046068 0051 | issued | 2031-06-23 |
G70 046068 0048 | issued | 2029-01-09 |
G15 046068 0067 | issued | 2029-02-06 |